Documents obtained by overseas media Filter provide insight into the U.S. Food and Drug Administration's early planning for its much-maligned premarket tobacco product application (PMTA) process to authorize e-cigarettes -- or not - suitable for the protection of public health.

They suggest, among other things, that the FDA could eventually envision a pathway to authorizing flavors other than tobacco and menthol, though it hasn't done so yet -- and the agency tends to favor the largest companies, mostly with tobacco industry ties, entrenched.

It's been an arduous journey. In June 2021, acting FDA commissioner Janet Woodcock faced sharp questions from lawmakers at a congressional hearing about the agency's failure to address teen vaping rates. Just over a week later, FDA's Center for Tobacco Products (CTP) sent an internal memo explaining how staff would deal with the backlog of millions of PMTAs they may not have anticipated. They will create a new fatal flaw strategy—they will use database queries to identify the top 12 manufacturers with the highest number of pending PMTAs for non-tobacco-flavored e-liquid products not under scientific review—and determine whether they contain random Controlled trials (RCTs) or longitudinal cohort studies.

None of these applications appeared to be available, and the agency issued a Marketing Denial Order (MDO) to all of them. Many manufacturers have since argued that the FDA never made it clear that such studies were needed, and dozens have filed suit in federal appeals courts, alleging the fatally flawed approach is arbitrary and capricious.

The PMTA process was vague from the start, despite the seemingly simple basic structure. There will be three distinct phases:

Stage I (Acceptance), which basically indicates that the application has been received; Stage II (Notification or Filing), which acknowledges that the PMTA has enough information to formally file; Stage III (Review), which involves a thorough scientific evaluation.

Companies expect that if their PMTA is missing key elements, the FDA will issue a defect letter, allowing them to respond and possibly improve any issues. Initially, this seemed to be the case.

But something seems to have changed along the way.

In November, Filter received a revised version of the Fatal Flaws memo showing how CTP's Office of Science (OS) has apparently moved from its original premarket application review priority program.

The exact content of the original plan is still unknown. But through a Freedom of Information Act (FOIA) request, Filter has now obtained a Premarket Application Review Priority Plan from the CTP Office of Science, signed by Director Matthew Holman on August 31, 2020. The memo is within a week or so before the PMTA submission deadline of September 9, 2020.

While the overall plan aligns with the FDA's extensive message -- its PMTA review process will focus on the companies with the largest market share -- it reveals how strict the prioritization has become.

The FDA did not respond to Filter's request for comment.

"As application submission deadlines approach, OS anticipates a significant increase in the number of premarket applications across all three premarket pathways," the plan reads. "In preparation for the increase...OS determined it was necessary to update the review process to ensure that we could effectively initiate and complete the review of as many applications as possible within the one-year compliance period, while applying the same scientific rigor sex."

The memorandum includes a series of guiding principles:

1. Simplicity: The chosen approach should be easy to manage, interpret and implement

2. Defendable: Decisions are not arbitrary and capricious

3. Flexibility: Processes provide the opportunity to easily adapt and adapt policies if needed

4. In support of our public health goals:

* Minimize youth initiation

* Ensuring opportunities for a variety of e-cigarettes to remain on the market to promote adult smokers switching to less harmful tobacco products.

It identified six manufacturers to prioritize: Juul Labs, in which Altria holds a minority interest; Reynolds, a subsidiary of British American Tobacco (BAT), which makes Vuse; NJOY; Fontem Ventures, a subsidiary of Imperial Tobacco, which makes blu; Cool Clouds Distributors, which makes puff bars; and Japan Tobacco International (JTI), which launches Logic.

The CTP ultimately ruled out Puff Bar because it ceased sales in July 2020 and ended up switching to synthetic nicotine.

It presents an enticing possibility about taste.

The prioritization plan then outlines how the CTP will handle PMTA, dividing employees into nearly 12 teams and creating different cohorts by level of importance: Cohort 1 handles "ENDS products from the five largest manufacturers by market share," prioritizing " Earliest PMTA received from each manufacturer;" Cohort 2 processes "PMTAs for all marketed deemed and legally regulated tobacco products other than Cohort 1", select "By randomly assigning each manufacturer to Review PMTAs”; Cohort 3 focuses on “unmarketed tobacco products deemed and legally regulated by PMTAs”, with priority given to “ENDS products containing devices that employ age-verification technology”.

A final note, regarding the products in Queue 3, raises a tantalizing possibility regarding flavors — widely blamed in the U.S. for an epidemic of teen vaping, which has so far been immediately rejected by the FDA, although harm reductionists point out , most adults switch from smoking to non-tobacco flavors.

Reading between the lines, it further acknowledges some of what the CTP has already mentioned in its Technical Program Leader (TPL), which was published two days before the September 9, 2020 deadline.

The FDA will consider device access restrictions (eg, technologies that require the identification of adult users by fingerprints or other biometric parameters to unlock and use tobacco products) when discussing mitigations to reduce the risk of youth enrollment, the TPL document states.

The FDA has already authorized some tobacco-flavored e-cigarettes and continues to criticize the decision on menthol vaping products. Because it effectively argues that marketing programs are insufficient to deter young people from using other flavors, age-verification technology may be one of the only ways manufacturers can license flavors.

In other words: a device with cutting-edge technology (like the UK's Juul2) might see flavors other than tobacco and menthol.

“I feel like this is a legitimate approach that might get FDA support,” Cliff Douglas, director of the University of Michigan Tobacco Research Network and former vice president of tobacco control at the American Cancer Society, told Filter.

The CTP didn't make it clear, and we don't know what those products were. But this possibility is likely to divide already polarized groups in tobacco control.

"I think these locking technologies are a really bad idea," Clive Bates, former director of the UK Action on Smoking and Health, told Filter. "There is no equivalent for cigarettes, and for many users, they involve considerable complexity and hurdles."

What is clear in the PMTA Priority Plan, however, is a very clear timeline that sheds light on how the FDA can adjust its priorities. We have compelling evidence that the odds are getting better compared to smaller manufacturers.

According to an addendum signed by Holman on September 24, 2020, which Filter also received via a FOIA request, products in Queue 2 will be randomly assigned and a defect letter will be sent for any incomplete PMTA.

"To ensure that the OS completes two scientific review cycles for each PMTA bundle selected for review within the one-year compliance period, the OS reduces the PMTA's scientific review cycle to 90 calendar days and allows applicants to Respond to defect letters within calendar days.” The priority plan reads “These timelines will enable the OS to initiate two sets of PMTA scientific reviews for each of the ten teams, assuming no extended time to respond to defect letters. "

This appears to have happened ahead of the fatal defect memo in mid-2021: Filter also reviewed three defect letters (dated from December 2020 to May 2021), and the FDA issued a request to manufacturers not identified as having the largest market share. These letters were issued by the merchants. The letters were largely identical, with strong demands such as “comparative health risk data”, more precise “ingredient characterization” and “relevant control parameters (such as temperature) during storage of the finished product before shipping. , humidity, duration) specific information.”

But by the time the Fatal Defects memo was released, the FDA had stopped sending such defect letters and simply issued MDOs, many of which are currently or have been dealt with in court. Turning Point Brands, for example, appears to have received an MDO through this revised process, and the agency eventually brought its PMTA back under review after the company filed a lawsuit.

Apparently, it's down to the luck of the small company: if a team at the CTP reviews your PMTA before the Fatal Defect Memo because it was randomly assigned in an early batch, you'll receive a defect letter; if it Haven't been assigned yet, or been assigned after the "Fatal Flaw" memo, and there's a good chance you'll be rejected outright.

"If you're a small to medium-sized manufacturer that spends a lot of time and money doing research but doesn't get into the RCT -- because you're not told you have to -- now you don't know what they think about the RCT for the rest of your application." A former CTP employee who requested anonymity told Filter. "Did you do your HPHC research right? Did you explain your manufacturing process correctly? What about your perception research? It would be unfair to many not to evaluate or even comment on these. Even a large company gets With the MDO, they also need to look at the whole review — which is a favor that smaller manufacturers don’t get.”

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